RAPA-Keloid Study of Keloid Regression

The University of Texas System (UT)

Status and phase: Completed; Early Phase 1

Conditions: Keloid

Treatments: Drug: Rapamycin 8% Ointment; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04049552

HSC20190291H

Details and patient eligibility

About

1. To test whether topical rapamycin regresses established keloids in humans by measuring surface area and height changes in the scar over time (6 months)
2. To test safety of product and feasibility of conduct for future clinical trial

Full description

This pilot trial will use daily 0.5-1.0 ml applications of 8% RAPA (Rapamycin) in a petrolatum vehicle to treat established keloid lesions in 5 persons with at least 2 chronic keloids in similar body regions (greater than 1-year duration). Treatment will be applied once daily for 6 months. One keloid will receive 8% RAPA ointment and the other keloid will receive petrolatum-only ointment as a control. Surface areas and height of keloids will be monitored pre- and post-treatment to evaluate responses.

Keloid surface area and height changes will be measured pre-treatment and thereafter on a monthly basis using standardized digital photography with a tripod-mounted 8MP Canon S5is camera and calipers to measure keloid height (37).

Surface areas of all photographed lesions will be measured with Image J (http://rsbweb.nih.gov/ij/index.html), a public image-processing program that was used to analyze preliminary data and this study will use the same approach.

Enrollment: 4 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject must have at least 2 keloid scars (for at least 1 year) in similar body locations that are easy to reach to apply ointment to
• Subject will be in good health with all chronic diseases (such as hypertension, coronary artery disease, etc.) clinically stable
• Cognitive functioning sufficient to provide informed consent
• Physically able to apply ointment to keloids daily
• Able to attend monthly clinic visits for 6 months

Exclusion criteria

• Diagnosis of diabetes
• Subjects taking the following medications: systemic steroid or immunosuppressant therapy within the past 6 months
• Local area steroidal treatment within the past 3 months
• History of allergy to rapamycin of petrolatum-based products

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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4 participants in 2 patient groups, including a placebo group

RAPA intervention

Experimental group

Description:

Rapamycin ointment will be applied to one keloid on the subject

Treatment:

Drug: Rapamycin 8% Ointment

Placebo

Placebo Comparator group

Description:

Placebo will be applied as a control on one keloid on the subject

Treatment:

Drug: Placebo